Recon: Pfizer, FDA work to head off shortages following tornado; Biogen to slash 1,000 jobs as cost-saving measure

• Pfizer, FDA work to ease shortage concerns as tornado relief efforts pick up (Fierce) (Washington Post) (FDAnews)
• FDA’s Decentralized Trial Guidance: Investigator, Health Care Provider Demarcation Raises Questions (Pink Sheet)
• U.S. FDA accepts supplemental New Drug Application for OFEV® (nintedanib) for children and adolescents aged 6-17 years old with fibrosing interstitial lung disease (BioSpace)
• The Gene Therapy Wave Is Here (Pink Sheet)
• White House Launches New Office To Tackle Pandemic Prep (MedTech Insight)
• Launch of arthritis drug biosimilars ramps up US pressure on pricing 'middlemen' (Reuters)
• White House unveils plan to make insurers cover mental health care (STAT) (Bloomberg) (Reuters)
• COVID-19 vaccine politics could be linked to excess GOP deaths in Ohio, Florida: study (The Hill)
• The AMA’s new president on medicine’s ‘AI era’ and the uncertain future of telehealth (STAT)

• EMA, US FDA Worry About AI’s Pitfalls And Promises (Pink Sheet)
• Principles-Based vs Prescriptive: How US & EU Compare In Their Approach To Decentralized Trials (Pink Sheet)
• Decades Old EU Radiopharmaceuticals Guide Needs To Reflect Novel Developments (Pink Sheet)
• Safety Concerns Prevented EU Approval For GSK’s Jesduvroq In Non-Dialysis CKD Patients (Pink Sheet)
• India suspends another drugmaker's licence over tainted cough syrup (Reuters)
• Medicines For Europe Requests Meeting With Lithuanian Legislature (Generics Bulletin)
• South African Court To Decide Whether COVID-19 Vaccine Contracts Should Be Published (Pink Sheet)
• "Last hope": Eager Germans are prepared to pay for weight-loss drug (Reuters)

• Biogen to Cut 1,000 Jobs as Part of $1B Cost Savings Plan (BioSpace) (STAT) (Reuters)
• Roche drops solid tumor option, intensifying the squeeze on SQZ (Fierce)
• Humanigen mulls bankruptcy after reverse merger falls through (Fierce) (Endpoints)
• Bayer slashes outlook as glyphosate demand weakens further (Reuters)
• J&J, GSK’s ViiV tout switching study showing patients prefer their long-acting HIV med Cabenuva over Gilead rival (Fierce) (Endpoints)
• Elevar Touts First-line Potential of Rivoceranib in Phase III Liver Cancer Trial (BioSpace)
• Alvotech Expands Biosimilar Collaboration with Teva Amid Manufacturing Woes (BioSpace)
• Astellas notches another protein degrader pact with $21M upfront for PeptiDream (Fierce)
• Heron lays off 25% of employees and renegotiates vendor contracts to save money (Fierce)
• To prevent cancer metastastis, prevent protein migration, new study suggests (Fierce)

• Consent Decree Looms As Philips Scores Q2 Growth In A Far From 'Business-As-Usual' Year (MedTech Insight)
• Abbott’s Lingo Biowearable For Consumers Debuts In The UK As Libre Momentum Continues (MedTech Insight)
• Old Tech, New Tricks: The ‘Game-Changing’ Potential In Thermal Imaging For Diabetes (MedTech Insight)
• Capitalizing on 3D-Printing for Medical Device Manufacturing (MD+DI)
• Baxter’s Proposed Kidney Spinoff Business Gets a Name (MD+DI) (BioSpace)
• Inspire Medical hires Medtronic veteran as new strategy chief (MedTechDive)

• J&J Jury’s Cancer Verdict Adds New Wrinkle to Bankruptcy Vote (Bloomberg)
• AbCellera hopes to restart patent infringement lawsuits against Berkeley Lights after US patent office denies rehearing (Endpoints)
• J&J Unit Seeks Vote Too Soon on Reorganization Plan, DOJ Says (Bloomberg)
• Generic Heart Drug Maker Zydus Beats Failure-to-Warn Claims (Bloomberg)
• Boehringer Sues Alvogen to Block Copies of Spiriva HandiHaler (Bloomberg)
• Exelixis, Teva reach settlement on Cabometyx patent dispute (Endpoints)
• Liquidia Fails to Undo Court’s Block on New Blood Pressure Drug (Bloomberg)